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Real-life use of elbasvir/grazoprevir in adults and elderly patients: a prospective evaluation of comedications used in the PITER cohort.

Title: Real-life use of elbasvir/grazoprevir in adults and elderly patients: a prospective evaluation of comedications used in the PITER cohort.
Authors: Quaranta MG; Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.; Rosato S; Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.; Ferrigno L; Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.; Amoruso DC; Department of Hepatology, Gragnano Hospital, Naples, Italy.; Monti M; Center for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.; Di Stefano P; Infectious Disease Unit, Spirito Santo General Hospital, Pescara, Italy.; Filomia R; Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy.; Biliotti E; Department of Clinical Medicine, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.; Migliorino G; Department of Infectious Disease, San Gerardo Hospital, Monza, Italy.; Russo FP; Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.; Degasperi E; Gastroenterology and Hepatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; Chemello L; Department of Medicine, University of Padua, Padua, Italy.; Brancaccio G; Department of Infectious Disease, Università della Campania Luigi Vanvitelli, Naples, Italy.; Blanc P; Infectious Disease Unit, Santa Maria Annunziata Hospital, Florence, Italy.; Cannizzaro M; Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy.; Barbaro F; Infectious and Tropical Diseases Unit, Azienda Ospedaliera di Padova, Padua, Italy.; Morsica G; Department of Infectious Diseases, San Raffaele Hospital, Milan, Italy.; Licata A; Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy.; Kondili LA; Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.
Corporate Authors: PITER collaborating group
Source: Antiviral therapy [Antivir Ther] 2020; Vol. 25 (2), pp. 73-81.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Language: English
Journal Info: Publisher: SAGE Publications Country of Publication: England NLM ID: 9815705 Publication Model: Print Cited Medium: Internet ISSN: 2040-2058 (Electronic) Linking ISSN: 13596535 NLM ISO Abbreviation: Antivir Ther Subsets: MEDLINE
Imprint Name(s): Publication: [London] : SAGE Publications; Original Publication: London : International Medical Press
MeSH Terms: Antiviral Agents/*therapeutic use ; Benzofurans/*therapeutic use ; Hepatitis C, Chronic/*drug therapy ; Imidazoles/*therapeutic use ; Quinoxalines/*therapeutic use; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Benzofurans/adverse effects ; Imidazoles/adverse effects ; Quinoxalines/adverse effects ; Age Factors ; Aged ; Aged, 80 and over ; Drug Combinations ; Drug Interactions ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome
Abstract: Background: In patients treated for HCV infection, potential drug-drug interactions (DDIs) can occur among direct-acting antiviral drugs (DAAs) and comedications used. The real-life effectiveness and safety of elbasvir/grazoprevir (ELB/GZR) among co-medicated HCV patients was evaluated.; Methods: We prospectively evaluated consecutive patients from 15 clinical centres participating in PITER who were treated with ELB/GZR and had been followed for at least 12 weeks after treatment. Data were prospectively collected on the use of comedications (including discontinuation, dose modification and addition of drugs) and potential DDIs with DAAs.; Results: Of the 356 patients with at least 12-week post-treatment follow-up (median age 67, range 50-88 years), 338 (95%) achieved sustained virological response. Of these, 219 (60%) had at least one comorbidity (median 2, range 1-6); information on comedication was available for 212 of them. Of 190 comedications used, 15 (8%) drugs were modified during ELB/GZR therapy, specifically in 9 (4%) patients they were interrupted, in 2 (1%) of whom, the comedication was interrupted before the DAA therapy because of potential DDI (that is, patients treated with carbamazepine); in 12 (6%) patients the comedications were modified in terms of dosage. In 29 (14%) patients, the comedications required monitoring when used with ELB/GZR, as well as with all available DAAs. Of the 190 drugs, 27 (14%) used in 67% of patients were free of DDIs when used with ELB/GZR, whereas they required monitoring if used with other DAA regimens.; Conclusions: The results of this prospective study support findings that ELB/GZR is effective and safe in most treated patients.
Substance Nomenclature: 0 (Antiviral Agents); 0 (Benzofurans); 0 (Drug Combinations); 0 (Imidazoles); 0 (Quinoxalines); 0 (elbasvir-grazoprevir drug combination)
Entry Date(s): Date Created: 20200404 Date Completed: 20211004 Latest Revision: 20211004
Update Code: 20260130
DOI: 10.3851/IMP3350
PMID: 32242526
Database: MEDLINE

Journal Article; Research Support, Non-U.S. Gov't